Evidence mapPaperPMID 39806707Full record

Trial reportBMJ open2024

Impact of dexmedetomidine-ropivacaine versus sufentanil-ropivacaine combination for epidural labour analgesia on neonatal outcomes: a pilot randomised clinical trial.

Ke-Xin Jin, Chun-Mei Deng, Ting Ding, Yuan Qu, Dong-Xin Wang

2 registry-linked trialsAbstract readClinical Trial, Phase IVComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05698407 phase4completednot on this map

Effect of Dexmedetomidine Plus Ropivacaine Versus Sufentanil Plus Ropivacaine for Epidural Labor Analgesia on Neonatal Outcomes: a Pilot Randomized Trial

TypeinterventionalSponsorPeking University First HospitalRan2023 to 2023Enrolled200ConditionsPregnancy RelatedArmsDexmedetomidine, Sufentanil
NCT07145775 phase4completednot on this mapstarted 2025, after this paper: background citation

Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine Combination for Epidural Labor Analgesia and Neonatal Outcomes: a Pilot Randomized Trial

TypeinterventionalSponsorPeking University First HospitalRan2025 to 2026Enrolled300ConditionsEpidural Analgesia, Labor Pain, Sufentanil, DexmedetomidineArmssufentanil-ropivacaine combination, dexmedetomidine-esketamine-ropivacaine combination 1, dexmedetomidine-esketamine-ropivacaine combination 2
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Ke-Xin Jin *Department of Anesthesiology, Peking University First Hospital, Beijing, China.
Chun-Mei Deng *Department of Anesthesiology, Peking University First Hospital, Beijing, China.
Ting DingDepartment of Anesthesiology, Peking University First Hospital, Beijing, China.
Yuan QuDepartment of Anesthesiology, Peking University First Hospital, Beijing, China.
Dong-Xin WangDepartment of Anesthesiology, Peking University First Hospital, Beijing, China dxwang65@bjmu.edu.cn wangdongxin@hotmail.com.ORCID 0000-0002-3205-1836

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the impact of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination for epidural labour analgesia on neonatal and maternal outcomes and test the feasibility of a future large, randomised trial.

designA randomised, double-blind, pilot clinical trial from 16 March 2023 to 15 June 2023.

settingA tertiary-care hospital in Beijing, China.

participants200 women aged≥18 years who had full-term single pregnancy and were scheduled for vaginal delivery with epidural analgesia.

interventionsEligible participants were randomly assigned in a 1:1 ratio to receive self-controlled epidural labour analgesia using ropivacaine supplemented with either dexmedetomidine (0.45 µg/mL for induction and 0.36 µg/mL for maintenance) or sufentanil (0.45 µg/mL for induction and 0.36 µg/mL for maintenance). MAIN OUTCOMES AND MEASURES: The primary endpoint was a composite of neonatal morbidity, including 1- or 5 min Apgar score<7, umbilical artery PH<7.1, requirement for immediate assisted ventilation and admission to neonatal ward or intensive care unit within 24 hours. Secondary and other endpoints included effect of analgesia and occurrence of adverse events. The feasibility of implementing the protocol was evaluated.

resultsAll 200 women were included in the intention-to-treat analysis. Composite neonatal morbidity occurred in 14.0% (14/100) of women with dexmedetomidine versus 17.0% (17/100) of women with sufentanil: relative risk 0.82, 95% CI 0.43 to 1.58. Women in the dexmedetomidine group had a comparable area under curve of pain intensity (median difference -2.0 point⋅h, 95% CI -9.9 to 5.9, p=0.638), required more self-controlled boluses (median difference two boluses, 95% CI 0 to 3, p=0.040) and epidural analgesics (median difference 17 mL, 95% CI 4 to 29, p=0.007), and experienced less pruritus (0.0% (0/100) vs 30.0% (30/100), p<0.001) but more lower limb weakness (13.0% (13/100) vs 1.0% (1/100), p<0.001). Recruitment rate was satisfactory (87.7%); the protocol was well accepted by anaesthesiologists and nurses.

conclusionsCompared with sufentanil-ropivacaine combination, use of dexmedetomidine-ropivacaine combination for epidural labour analgesia was associated with a 18% decrease in composite neonatal endpoint and deserve further investigation. The dexmedetomidine-ropivacaine combination provided comparable analgesia but increased mild motor block. The conduct of a large, randomised trial using same protocol requires careful re-evaluation. TRIAL REGISTRATION NUMBER: NCT05698407.

Indexed as

Analgesia, EpiduralAnalgesia, ObstetricalAnesthetics, LocalDexmedetomidineRopivacaineSufentanilAdultAnalgesics, OpioidApgar ScoreChinaDouble-Blind MethodDrug Therapy, CombinationFemaleHumansInfant, NewbornPilot ProjectsAnalgesics, OpioidAnesthetics, LocalDexmedetomidineRopivacaineSufentanilAnaesthesia in obstetricsANAESTHETICSPain management

Identifiers

PMID39806707
PMCPMC11667271

What Socratic holds

Textmetadata
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.